FUJI BOND LC

Agent, Tooth Bonding, Resin

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Fuji Bond Lc.

Pre-market Notification Details

Device IDK953166
510k NumberK953166
Device Name:FUJI BOND LC
ClassificationAgent, Tooth Bonding, Resin
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactTerry L Joritz
CorrespondentTerry L Joritz
GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-07
Decision Date1995-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
24548161293652 K953166 000
24548161282861 K953166 000
24548161282496 K953166 000

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